MAUDE Adverse Event Report: LEICA BIOSYSTEMS PTY. LTD. PELORIS RAPID TISSUE PROCESSOR; AUTOMATED TISSUE PROCESSOR

Model Number PELORIS II

Device Problem Device Issue (2379)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/06/2018

Event Type  malfunction  

Manufacturer Narrative

Specific details of the protocol(s) used to process tissue samples from which sub-optimal processing was reported following preventive maintenance performed on (b)(6) 2018, were not provided by the complainant and could not be identified by the manufacturer from the information available.Manufacturer evaluation of the instrument logs provided showed that bottles 1-16 inclusive were removed from the instrument (most likely for inspection of the o-ring on each bottle as required by the pm procedure) and were subsequently replaced between 09:20 am and 10:12 am on (b)(6) 2018 without changing the station properties.It is not possible to determine from the information available into which position in the reagent cabinet of the instrument each of the reagent bottles was re-inserted after removal by the fse.Investigation of this complaint found that the root cause of the sub-optimal tissue processing reported was a service error, which occurred between 09:20 am and 10:12 am on (b)(6) 2018, in which the instrument was incorrectly prepared for use by a leica field service engineer during the performance of preventive maintenance when an unknown number of reagent bottles were inadvertently not placed in the correct position in the reagent cabinet of the instrument.Incorrect placement of the reagent bottles in the reagent cabinet would likely have resulted in either the use an incorrect reagent type and/or use of a reagent in an incorrect concentration sequence being used in the affected protocol(s).

Event Description

Leica biosystems received information on 12 march 2018 that sub-optimal tissue processing occurred.On 15 march 2018, a leica representative documented that the senior histology technician of surgical pathology from the department of pathology at the university (b)(6) had been contacted on both 12 and 14 march 2018 regarding the final status of the tissue samples involved in this event and had confirmed on both occasions that all cases exhibiting sub-optimal tissue processing had been signed off.Further information received on 15 march 2018, detailed that during preventive maintenance performed on (b)(6) 2018 a leica field service engineer had accidently replaced some reagent bottles in the reagent cabinet of the instrument in an incorrect order; the customer had subsequently used the instrument to process tissue samples, which resulted in brittle tissue.

• Brand Name: PELORIS RAPID TISSUE PROCESSOR
• Type of Device: AUTOMATED TISSUE PROCESSOR
• Manufacturer (Section D): LEICA BIOSYSTEMS PTY. LTD.; 495 blackburn road; mount waverley, vic 3149 ; AS 3149
• Manufacturer (Section G): LEICA BIOSYSTEMS MELBOURNE PTY.LTD; 495 blackburn road; mount waverley, victoria 3149 ; AS 3149
• Manufacturer Contact: adrienne hardisty ; 495 blackburn road; mount waverley, victoria 3149 ; AS 3149
• MDR Report Key: 7401710
• MDR Text Key: 104870140
• Report Number: 8020030-2018-00015
• Device Sequence Number: 1
• Product Code: IEO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: PELORIS II
• Device Catalogue Number: 26.0008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/17/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1